A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes

November 15, 2015 updated by: Zhiming Zhu, Third Military Medical University

What is the Effects of Prokinetic Drug on the Blood Glucose in Type 2 Diabetes Patients: Mosapride Comparing Placebo

With the improvement of living level, the incidence rates of diabetes, obesity, and hypertension in China increased quickly, which are 11.6%, 7.1% and 18.8% respectively, according to the newly investigated data. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Sleeve gastrectomy can improve the level of blood glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level and insulin resistance, which may be related with the change of gastrointestinal hormones such as ghrelin and GLP-1. So, intervention of gastrointestinal tract and gastrointestinal hormone secretion may be a new therapy for glycolipids disorder and vascular complications. But, it is lack of evidence-based medicine proof on the relationship between prokinetic drug and glycolipids metabolism. So, the investigators designed a prospective, randomized, double-blinded, placebo control study, and try to evaluate the effects of prokinetic drug (Mosapride) on the blood glucose and serum lipid in type 2 diabetic patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Zhu Zhiming, MD, PhD
  • Phone Number: 86-023-68767849
  • Email: zhuzm@yahoo.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age between 30-65 years old
  • Type 2 diabetes
  • Duration of diabetes less than 5 years and pancreatic function be in compensated stage.
  • 7%≤HbA1C≤9%
  • Patients are able to control diet and exercise by themselves in intervention period.

Exclusion Criteria:

  • Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
  • Type 2 diabetes using insulin, GLP-1 analogues or DPP-IV inhibitors).
  • Heart function in NYHA Grade II-IV or history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
  • Hypohepatia (AST or ALT is two times higher than the upper limit) or history of cirrhosis, hepatic encephalopathy, esophageal varices or portal shunt.
  • Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
  • Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
  • Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
  • Fertile woman without contraceptives.
  • Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
  • Allergic to or have contraindication to the intervention drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Mosapride
Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Drug: Mosapride
Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Placebo Comparator: Placebo
Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Drug: Placebo
Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change of fasting plasma glucose (FPG,mmol/L)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of OGTT 2 hour blood glucose(mmol/L)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of HbA1c(%)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of control rate of blood glucose(%)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change of insulin release(uU/mL)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of C peptide release(nmol/L)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of HOMA-β[HOMA-β=20×（FINS,mIU/L）/（（FPG,mmol/L）-3.5）]
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of HOMA-IR [HOMA-IR=(FPG,mmol/L）×（FINS,mIU/L）/22.5]
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of blood glucose variability(%)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of triglyceride(mmol/L）
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of total cholesterol(mmol/L）
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of LDL-c(mmol/L）
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of HDL-c(mmol/L）
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of Glucagon(pg/ml).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of GLP(pg/ml).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of GIP(pg/ml).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of DPP-IV(pg/ml).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of waist circumference (WC,cm)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of body fat(%).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of carotid intima-media thickness (IMT,mm).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of 24-hours urine sodium(mmol/24h)
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of 24-hours microalbumin(mg/L).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of 24-hours mALB/Cr(mg/g.Cr).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of inflammatory markers(hs-CRP,mg/L).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Incidence rate of newly-diagnosed hypertension(%).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Heart rate variability(HRV,%).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)
Change of clinic blood pressure and 24h mean blood pressure(mmHg).
Time Frame: Baseline, 24weeks (End of Trial)
Baseline, 24weeks (End of Trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Third Military Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Zhu Zhiming, MD, PhD, The third hospital affiliated to the Third Military Medical University. China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PDBG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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